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Should The Scope And Extent Of Validation Be Based On Risk? |
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Answer» Yes, the scope and extent of validation should be based on RISK according to the manufacturer's quality risk management procedures. QUALIFICATION and validation WORK is required to control the critical aspects of the particular OPERATION and a common sense approach should be applied. Yes, the scope and extent of validation should be based on risk according to the manufacturer's quality risk management procedures. Qualification and validation work is required to control the critical aspects of the particular operation and a common sense approach should be applied. |
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